| Interventions |
The study consists of 3 planned dose cohorts where each cohort will enrol a total of 8 participants of which 6 randomised to TP-317 treatment arm and 2 randomised to the placebo treatment arm. A total of 24 participants will be enrolled for this study. The planned dosed cohorts are as follows: Cohort 1 - Single oral dose of TP-317 10mg or Placebo tablets Cohort 2- Single oral dose of TP-317 40mg or Placebo tablets Cohort 3- Single oral dose of TP-317 80mg or Placebo tablets Participants will be administered oral tablet(s) under fasted condition (no food or water 10 hours prior and no food for 4 hours post dose and no water for 2 hours post-dose) on Day 1 . A designated unblinded pharmacist or other qualified personnel at the clinical site will be responsible for administering the study medication Each Cohort will be administered to a distinct group of participants and observed for 24 hours post dose before proceeding with dosing the other planned cohort participants. Safety review committee will determine to proceed with subsequent cohorts after reviewing the safety data. |